Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders (UG3/UH3 Clinical Trial Optional) | RFA DA 25 028

Opportunity Information: Apply for RFA DA 25 028

This funding opportunity, RFA-DA-25-028, is a National Institutes of Health cooperative agreement aimed at speeding up the development of new treatments for opioid and stimulant use disorders by building better ways to measure whether treatments work. The core focus is the development of Clinical Outcome Assessments (COAs) for substance use disorders (SUD), meaning tools that can reliably and meaningfully capture patient outcomes in clinical studies. These COAs are expected to be advanced toward the FDA Drug Development Tool (DDT) Qualification Program so they can ultimately be used broadly across drug development programs within a clearly defined context of use for SUD. In practical terms, the grant is trying to increase the number and quality of outcome measures that FDA recognizes as fit-for-purpose, which can reduce uncertainty in clinical trials and make it easier to compare results across studies and interventions.

The award uses the UG3/UH3 Phased Innovation Awards mechanism, which is designed for projects that need an early, milestone-driven development period before moving into a larger implementation and validation phase. The first stage is the UG3 phase, lasting up to two years, and it must include concrete, operational milestones that can be evaluated at the end of the period. These milestones function like decision points: investigators need to show they have made sufficient progress on the COA development plan to justify continued support. If the National Institute on Drug Abuse (NIDA) determines the UG3 milestones have been successfully met, the project can transition into the UH3 phase, which provides up to three additional years of support. The UH3 period is intended for the next level of work, such as more extensive testing, validation, refinement, and preparation for FDA qualification steps aligned with the proposed context of use.

A defining feature of this opportunity is that it is a cooperative agreement, not a standard research project grant. That typically means NIH/NIDA program staff are expected to have substantial involvement during the life of the project, particularly around milestone tracking, alignment with the FDA qualification pathway, and ensuring the work stays on a trajectory that supports eventual regulatory usefulness. The overall goal is to expand the field's "armamentarium" of FDA-qualified COAs as drug development tools specifically for substance use disorders. If successful, this helps the therapeutic pipeline by giving sponsors and researchers stronger, accepted endpoints and outcome measures for trials in opioid and stimulant use disorders, which can shorten development timelines, improve interpretability of trial results, and reduce the risk that promising treatments fail because outcomes were measured inconsistently or with tools that regulators consider inadequate.

The NOFO also places a firm requirement on including a Plan for Enhancing Diverse Perspectives (PEDP). This plan is not optional and is explicitly reviewed as part of scientific and technical peer review. Applications that do not include a PEDP are considered incomplete and will be withdrawn, which makes it a true compliance item, not just a suggestion. The intent of the PEDP is to ensure the project meaningfully incorporates diverse perspectives into the research and development process, which is especially relevant for SUD outcomes given differences in lived experience, access to care, stigma, comorbidities, and community context. Applicants are encouraged by the agency to closely follow the specific NOFO instructions and consult PEDP guidance materials to meet expectations.

Eligibility is broad and includes many types of domestic applicants such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The NOFO also highlights additional eligible groups and institution types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations. This wide eligibility reflects the reality that developing robust COAs for SUD often benefits from multi-sector participation, including clinical researchers, measurement scientists, community partners, and organizations with access to diverse patient populations.

Administratively, the opportunity is categorized as discretionary funding and uses the Cooperative Agreement instrument type under an education and health activity category, with CFDA number 93.279. The original closing date listed for applications was 2024-07-09, and the posting information indicates a creation date of 2023-12-18. While an award ceiling and expected number of awards are not specified in the provided data, the structure of the UG3/UH3 mechanism implies NIH will be looking for proposals with realistic timelines, well-defined milestone criteria, a credible strategy for measurement development and validation, and a clear line of sight to FDA DDT qualification within a specified context of use relevant to opioid and stimulant use disorders.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2023-12-18.
• Applicants must submit their applications by 2024-07-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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